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Bladder CancerPhase 1NCT00471432

OGX-011 and Docetaxel in Treating Patients With Metastatic or Locally Recurrent Solid Tumors

A Phase 1 study testing custirsen sodium, docetaxel and pharmacological study in people with Bladder Cancer and Breast Cancer, run by NCIC Clinical Trials Group.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: OGX-011 may kill tumor cells by blocking some of the proteins that may cause tumor cells to grow. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Bladder Cancer, Breast Cancer, Kidney Cancer
What is being tested?
custirsen sodium, docetaxel and pharmacological study
How many people
40 participants
Where
No sites listed yet
Study dates
4 Apr 2003to 21 Dec 2009
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed solid tumors that have been shown to overexpress clusterin, including but not limited to, any of the following:
  • Prostate cancer
  • Renal cell carcinoma
  • Non-small cell lung cancer
  • Bladder cancer
  • Breast cancer
  • Ovarian cancer
  • Metastatic or locally recurrent disease
  • Refractory to standard curative therapy or no standard curative therapy exists
  • Patients with prostate cancer must be hormone refractory (i.e., have documented evidence of progression while receiving androgen ablative therapy)
  • Measurable or nonmeasurable disease
  • Measurable disease defined as measurable lesion ≥ 20 mm by x-ray, physical exam, or nonspiral CT scan or ≥ 10 mm by spiral CT scan
  • No documented CNS metastases
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Menopausal status not specified
  • ECOG performance status 0-2
  • Life expectancy ≥ 12 weeks
  • Absolute granulocyte count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Bilirubin normal
  • Creatinine ≤ 2 times upper limit of normal (ULN)
  • AST and ALT ≤ 1.5 times ULN
  • PT/INR and PTT normal
  • No uncontrolled pain
  • No known bleeding disorder
  • No history of serious allergic reaction to taxane (paclitaxel or docetaxel)
  • No preexisting peripheral neuropathy ≥ grade 2
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other serious illness or medical conditions that would preclude study compliance, including any of the following:
  • Active uncontrolled infection
  • Significant cardiac dysfunction
  • No significant neurological disorder that would preclude giving informed consent

PRIOR CONCURRENT THERAPY:

  • No prior strontium chloride Sr 89
  • No more than 2 prior chemotherapy regimens, including adjuvant or neoadjuvant chemotherapy (for patients assigned to schedule B [docetaxel once every 3 weeks])
  • More than 4 weeks since prior chemotherapy and recovered
  • At least 4 weeks since prior antiandrogens
  • More than 4 weeks since prior external-beam radiotherapy, except low-dose nonmyelosuppressive radiotherapy
  • No prior radiotherapy to ≥ 30% of marrow-bearing areas (for patients assigned to schedule B [docetaxel once every 3 weeks])
  • At least 28 days since prior new anticancer therapy
  • At least 28 days since prior and no other concurrent investigational agents
  • No concurrent radiotherapy, except low-dose nonmyelosuppressive radiotherapy
  • No other concurrent cytotoxic therapy
  • Concurrent luteinizing hormone-releasing hormone agonist allowed (if already initiated in patients with prostate cancer)
  • No concurrent anticoagulant therapy (i.e., heparin, warfarin)

About this study

Official title: A Phase I Study of a Second Generation Clusterin Antisense Oligonucleotide (OGX-011) in Combination With Docetaxel

RATIONALE: OGX-011 may kill tumor cells by blocking some of the proteins that may cause tumor cells to grow. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving OGX-011 together with docetaxel may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of OGX-011 when given together with docetaxel in treating patients with metastatic or locally recurrent solid tumors.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the dose-limiting toxicity and recommended phase II dose of OGX-011 when administered with docetaxel in patients with metastatic or locally recurrent solid tumors.

Secondary

  • Determine the pharmacokinetic profile of this regimen in these patients.
  • Assess the effect of OGX-011 on serum clusterin levels and clusterin expression in peripheral blood mononuclear cells and accessible tumors.
  • Assess objective response in patients treated with this regimen.

OUTLINE: This is an open-label, multicenter, dose-escalation study of OGX-011. Patients are sequentially assigned to 1 of 2 treatment schedules.

  • Schedule A: Patients receive OGX-011 IV over 2 hours on days 1, 3, 5, 8, 15, 22, 29, and 36 of course 1 and once weekly in weeks 1-6 of all subsequent courses. Patients also receive docetaxel IV over 1 hour once weekly in weeks 1-5. Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
  • Schedule B: Patients receive OGX-011 IV over 2 hours on days -7, -5, -3, 1, 8, and 15 of course 1 and days 1, 8, and 15 of all subsequent courses. Patients also receive docetaxel IV over 1 hour on day 1. Treatment repeats every 3 weeks (course 1 is 4 weeks in duration) for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of OGX-011 (in each schedule) until the recommended phase II dose (RPTD) is determined. The RPTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients undergo serum collection periodically for pharmacokinetic and pharmacodynamic analysis.

After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Being tested
custirsen sodium, docetaxel, pharmacological study
Keywords
recurrent prostate cancer, stage IV prostate cancer, recurrent renal cell cancer, stage IV renal cell cancer, recurrent non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent bladder cancer, stage IV bladder cancer, recurrent breast cancer, stage IV breast cancer, recurrent ovarian epithelial cancer, stage IV ovarian epithelial cancer, unspecified adult solid tumor, protocol specific, male breast cancer
Medical subject headings
Urinary Bladder Neoplasms, Breast Neoplasms, Kidney Neoplasms, Lung Neoplasms, Ovarian Neoplasms, Prostatic Neoplasms, Carcinoma, Renal Cell, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-limiting toxicity

  2. Recommended phase II dose of OGX-011

Secondary outcomes (3)

  1. Pharmacokinetic profile

  2. Serum clusterin levels and clusterin expression in peripheral blood mononuclear cells and accessible tumors

  3. Objective response

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2007 (estimated)
  2. Study start4 Apr 2003
  3. Primary completion9 Mar 2006
  4. Study completion21 Dec 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00471432
Sponsor's protocol ID
I154
Other IDs
CAN-NCIC-IND154, ONCOGENEX-OGX-01-02, CDR0000547039
Status last verified
Apr 2020
First submitted
8 May 2007
Last updated
4 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chi KN, Siu LL, Hirte H, Hotte SJ, Knox J, Kollmansberger C, Gleave M, Guns E, Powers J, Walsh W, Tu D, Eisenhauer E. A phase I study of OGX-011, a 2'-methoxyethyl phosphorothioate antisense to clusterin, in combination with docetaxel in patients with advanced cancer. Clin Cancer Res. 2008 Feb 1;14(3):833-9. doi: 10.1158/1078-0432.CCR-07-1310.

    PubMed 18245546

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing custirsen sodium, docetaxel and pharmacological study in people with Bladder Cancer and Breast Cancer, run by NCIC Clinical Trials Group.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00471432, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2023.

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